Dormikind (Tablets) Instructions for Use

Marketing Authorization Holder

Alpen Pharma, GmbH (Germany)

Manufactured By

Deutsche Homoeopathie Union-Arzneimittel GmbH & Co. KG (Germany)

Or

Dr. Gustav Klein GmbH & Co. KG (Germany)

Contact Information

ALPEN PHARMA LLC (Russia)

Dosage Form

Dormikind

Homeopathic lozenges for children: 150 pcs.

Dosage Form, Packaging, and Composition

Homeopathic lozenges for children are white in color, flat-cylindrical in shape, with a bevel.

Excipients: lactose monohydrate – 29.85 mg, microcrystalline cellulose – 15 mg, talc – 5 mg, magnesium stearate – 0.15 mg.

150 pcs. – brown glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Homeopathic preparation with hypnotic action

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

A complex homeopathic preparation, the action of which is due to the components that make up its composition.

Pharmacokinetics

Pharmacokinetic data for the drug Dormikind are not provided.

Indications

• For the treatment of restlessness and sleep disorders (difficulty falling asleep, restless sleep) in children under 6 years of age.

ICD codes

Dosage Regimen

The tablets should be taken half an hour before or half an hour after a meal, slowly dissolving in the oral cavity. When treating infants and young children, the tablets can be dissolved in 5 ml (1 teaspoon) of water.

Unless otherwise specified, Dormikind should be prescribed to children aged 0 to 6 years 1 tablet 4 times/day. The maximum course of treatment with the drug is 4 weeks.

If there is no improvement while using the drug for 14 days or if adverse events occur, a doctor should be consulted.

Adverse Reactions

Possible allergic reactions and reactions of individual intolerance.

If side effects occur, a doctor should be consulted.

Contraindications

• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Increased individual sensitivity to individual components of the drug.

Use in Pregnancy and Lactation

The drug is not used in this category of patients.

Special Precautions

When using homeopathic medicinal products, a temporary exacerbation of symptoms may be observed; in this case, a doctor should be consulted.

If there is no therapeutic effect within 14 days, as well as if side effects appear, a doctor should be consulted.

Patients with diabetes mellitus should take into account that the carbohydrate content in the maximum daily dose of the drug (4 tablets) corresponds to 0.026 bread units (BU).

Effect on the ability to drive vehicles and operate machinery

The drug is used only in children.

Overdose

Cases of overdose have not been reported to date.

Drug Interactions

To date, there is no information on the interaction of the drug Dormikind with other medicinal products.

If the child is taking or has recently taken other drugs, including those that can be purchased without a prescription, a doctor should be informed about this.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.